Dr. Reddy's Recalls Progesterone Capsules Due to Dissolution Failures
Dr. Reddy's Laboratories is recalling 16,449 bottles of 200 mg Progesterone Capsules because stability testing revealed out-of-specification dissolution results.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, which typically involves a situation where use of, or exposure to, the product may cause temporary or medically reversible adverse health consequences. The hazard is a quality control failure (dissolution) rather than a direct acute safety threat like contamination or structural failure.
Plain-English summary
Dr. Reddy's Laboratories, Inc. is recalling 16,449 bottles of Progesterone Capsules, 200 mg, 100-count bottles. The product is a prescription-only medication (NDC 43598-350-01) manufactured in France and distributed nationwide in the USA by Dr. Reddy's Laboratories, Inc., located in Princeton, NJ. The specific batch involved is # 1399851P1 with an expiration date of 02/2021.
The recall was initiated because out-of-specification results were observed for dissolution during stability testing. This means the capsules may not release the medication at the required rate, potentially affecting the drug's performance.
Consumers and healthcare providers should stop using the recalled product and contact their pharmacist or Dr. Reddy's Laboratories for a replacement or refund. Patients should consult their healthcare provider regarding alternative treatment options.
The recalled product
- Product
- PROGESTERONE (PROGESTERONE)
- Brand
- PROGESTERONE
- Manufacturer
- Dr. Reddy's Laboratories, Inc.
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 16,449
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Batch # 1399851P1
- Exp 02/2021
Distribution
Distributed nationwide across the United States.
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