Adalat CC (nifedipine) Extended-Release Tablets, 90 mg, 100-count bottles, Rx Only, Manufactured ...
FDA Drug Recall #D-0635-2017 — Class III — March 7, 2017
Recall Summary
| Recall Number | D-0635-2017 |
| Classification | Class III — Low risk |
| Date Initiated | March 7, 2017 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Alvogen, Inc |
| Location | Pine Brook, NJ |
| Product Type | Drugs |
| Quantity | N/A |
Product Description
Adalat CC (nifedipine) Extended-Release Tablets, 90 mg, 100-count bottles, Rx Only, Manufactured for Almatica Pharma Inc. Pine Brook, NJ 07058 USA, NDC 5242749601
Reason for Recall
Cross Contamination with another product:residual powder found in inlet air duct identified as sorafenib
Distribution Pattern
Nationwide
Lot / Code Information
Lot #: BXHD7U1A, Exp. 10/2018
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|---|---|---|---|
| D-0259-2026 | Class II | Levothyroxine Sodium Tablets, USP, Thyro-Tabs, ... | Dec 31, 2025 |
| D-0245-2025 | Class I | Fentanyl Transdermal System CII, 25mcg/h, packa... | Jan 31, 2025 |
| D-0353-2023 | Class II | Levothyroxine Sodium Tablets, USP 112 mcg, 90 t... | Feb 6, 2023 |
| D-0649-2021 | Class II | Buprenorphine and Naloxone Sublingual Film 2mg/... | Feb 26, 2021 |
| D-1723-2019 | Class II | Macrobid Urinary Tract Anitbacterial, 100 mg, ... | Jul 24, 2019 |
Frequently Asked Questions
Injectable drugs and eye drops must be completely free of microbial contamination because they bypass the body's natural defenses. A contaminated injectable can introduce bacteria or fungi directly into the bloodstream, potentially causing sepsis, meningitis, or localized infections — all of which can be life-threatening. Contamination of sterile products almost always results in a Class I recall. If you received an injectable drug from a recalled lot, contact your healthcare provider immediately, even if you feel well, as some infections can have delayed onset.
Not necessarily. Many drug recalls are initiated because of quality system failures or test results that suggest a product might not meet specifications — even if no patients have reported harm. The FDA uses a precautionary approach: if there is reason to believe quality standards were not met, a recall is required regardless of whether adverse effects have been reported. Class I recalls typically involve a reasonable probability of harm; Class II recalls may cause temporary health issues; Class III recalls are for products unlikely to cause adverse health consequences but that still violate regulations.
Pharmacies typically receive recall notices directly from drug wholesalers and manufacturers within days of the recall being announced. Your pharmacist can look up whether any product in your prescription history matches a recalled lot number. For current recalls, the FDA publishes updates at FDA.gov/safety/recalls-market-withdrawals-safety-alerts and sends MedWatch email alerts for significant drug safety issues. You can sign up for MedWatch alerts at FDA.gov. Most major pharmacy chains also have their own recall notification systems that automatically alert pharmacists when a recalled product is in their inventory.
What Should You Do?
Stop using this medication if affected by this recall. Contact your pharmacist or prescribing doctor immediately for guidance. Do not flush medications — use a drug take-back program.